To prove that the NANOS prosthesis is a good prosthesis to be used in total hip replacement surgery, with low revision rate (< 10%) after 10 years. This percentage is known in the Swedish registry.Second objective is to prove that clinical…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival rate at 10 years follow- up.
Secondary outcome
Clinical outcome: HHS, HOOS, UCLA and radiographic findings.
Background summary
Short-stemmed femoral shaft prostheses, have been introduced especially for
younger patients. These endo-prostheses are anchored exclusively in the
metaphysic and the proximal part of the diaphysis. Therefore, they are much
shorter than the classic standard stems. Short femoral neck implants are
claiming less interference with the biomechanics.
The NANOS femoral neck prosthesis has been developed based on clinical
experience of various *short stem prostheses* and is the third generation of
this type of prostheses. The implant requires only minimal bone resection.
Therefore a maximum amount of bone is preserved. The cancellous bone around the
metaphysic and the greater trochanter are retained to ensure load distribution
and transfer.
The surface roughness of the titanium plasma coating on one hand increases the
surface area and on the other hand ensures superior primary stability. The
additional calcium phosphate coating allows accelerating the osseointegration
process.
Study objective
To prove that the NANOS prosthesis is a good prosthesis to be used in total hip
replacement surgery, with low revision rate (< 10%) after 10 years. This
percentage is known in the Swedish registry.
Second objective is to prove that clinical outcome (Harris Hip Score, HOOS,
UCLA and radiological findings) is comparable to clinical results of other
short stemmed femoral shaft prostheses, known from literature.
Study design
Prospective, multicenter, observational clinical outcome study.
Study burden and risks
This is an observational study with no extra interventions for the patients, as
just completing one questionnaire which can be done while waiting to see the
surgeon at control visits.
Oberneuhofstrasse 10d
Baar 6340
CH
Oberneuhofstrasse 10d
Baar 6340
CH
Listed location countries
Age
Inclusion criteria
Patients with degenerative hip disease, age 18-60, requiring a primary neck preserving hip arthroplasty (page 6).
Exclusion criteria
Previous failed endoprosthesis, active local or systemic infection, general health with ASA>2, pronounced femur neck angle of <125 or >145 degrees, insufficient bone stock (femur or acetabulum), proven osteoporosis, body mass index >30. (page 7).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30123.094.10 |